Regulatory Watch - Pharmaceutical Technology

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PharmTech

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PharmTech Europe

Regulatory Watch

Extending the Scope of Pharmacovigilance Comes at a Price

September 2, 2014

Pharmaceutical Technology

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Data Integrity Key to GMP Compliance

September 2, 2014

Pharmaceutical Technology

FDA demands accurate manufacturing and test information to ensure product quality.

Changes and Challenges for Generic Drugs

August 2, 2014

Pharmaceutical Technology

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

Industry Seeks Clearer Standards for Track and Trace

July 2, 2014

Pharmaceutical Technology

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Global Expansion Shapes Drug Oversight

June 2, 2014

Pharmaceutical Technology

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Regulating the Environmental Impact of Pharmaceuticals

June 2, 2014

Pharmaceutical Technology

Concern by environmentalists, regulators and manufacturers rises over the environmental impact of pharmaceuticals.

Demand for New Vaccines Spurs Innovation

May 2, 2014

Pharmaceutical Technology

New formulations and expanded vaccine production are encouraged.

Quality by Design—Bridging the Gap between Concept and Implementation

April 2, 2014

Pharmaceutical Technology

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

FDA and Manufacturers Seek a More Secure Drug Supply Chain

April 2, 2014

Pharmaceutical Technology

New identifiers and tracking requirements aim to block illegitimate products.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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